A study looking at nelfinavir and chemoradiotherapy for pancreatic cancer (SCALOP-2)

Cancer type:

Status:

Phase:

This study is for people who have pancreatic cancer that hasn’t spread to other parts of the body but can’t be removed with surgery. We call this locally advanced cancer.

There are 2 stages to this study. The first stage looked at finding the best dose of nelfinavir to have with chemoradiotherapy. The 2nd stage is looking at having this dose with chemoradiotherapy.

Cancer Research UK supports this trial.

More about this trial

Treatment for locally advanced pancreatic cancer is usually either chemotherapy alone or a combination of chemotherapy and radiotherapy (chemoradiotherapy). But these treatments do not get rid of the cancer and so doctors are looking at how they can improve these treatments.

In this study, doctors want to see if increasing the dose of radiotherapy works better. They also want to see if having a drug called nelfinavir with a chemotherapy and radiotherapy makes the treatment better. The chemotherapy drug you have in this trial is capecitabine.

Nelfinavir is a type of drug called an antiretroviral. It is a treatment for human immunodeficiency virus (HIV). Doctors think it might help radiotherapy to work better. They think that it does this by increasing the amount of oxygen and blood supply to the cancer. This will make the cancer cells more sensitive to the effects of the radiotherapy.

The aims of this study are to:

find the best dose of nelfinavir

learn about the side effects of combining nelfinavir, capecitabine and radiotherapy

find out if increasing the dose of radiotherapy can help people live longer

find out if adding nelfinavir to chemoradiotherapy can delay the cancer coming back

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can enter

You may be able to join this study if all of the following apply. You:

have been diagnosed with pancreatic cancer and are unable to have surgery to remove this (locally advanced pancreatic cancer)

Women who take part and who could possibly become pregnant must be willing to use reliable contraception during their:

chemotherapy and for 1 month afterwards

chemoradiotherapy and for 6 months afterwards

Men who take part who have a partner who could possibly become pregnant must be willing to use reliable contraception during their:

chemotherapy and for 3 months afterwards

chemoradiotherapy and for 3 months afterwards

Who cannot enter

You can’t join this study if any of these apply.

Cancer related

You:

have pancreatic cancer that can be removed by surgery

have a type of cancer of the pancreas called lymphoma or a neuroendocrine tumour

have cancer that has spread elsewhere in the body (metastatic disease)

have pancreatic cancer that has come back after surgery

have had any other cancer in the last 3 years, apart from carcinoma in situ of the cervix or basal cell skin cancer that was successfully treated or another early stage cancer that was successfully treated and there haven’t been any signs of any cancer for at least 3 years

have had radiotherapy to your upper abdomen

have had any experimental treatment, including chemotherapy and immunotherapy, within 6 weeks of joining the study

Medical conditions

You:

are taking the following drugs and you are not able to stop them during the time you have chemoradiotherapy- sorivudine and analogues such as brivudine, methotrexate, allopurinol, dipyridamole

have any problem with your kidneys such as adult polycystic kidney disease or hydronephrosis that would stop you being able to have radiotherapy

have heart problems such as coronary artery disease which is not controlled by medication or you have had a heart attack or stroke in the last 6 months

have haemophilia A or B

have chronic hepatitis B or hepatitis C

have HIV

have low levels of a protein called DPD (this helps your body to break down chemotherapy)

People having chemoradiotherapy start it within 4 to 6 weeks of finishing your last dose of chemotherapy. The treatment will last for 5 ½ weeks or 6 weeks. Everyone has:

radiotherapy- Monday to Friday

capecitabine tablets twice a day - Monday to Friday

Some people also have nelfinavir tablets twice a day. You start these 7 days before starting radiotherapy and you take them every day until the end of radiotherapy.

You take both capecitabine and nelfinavir after a meal, for example breakfast and an evening meal. Or with as much food you can manage.

You record the days and times you take your tablets on a diary card the nurse gives you. A research nurse checks your diary card when you go for treatment.

Further chemotherapy, no radiotherapy

In this group, you have 2 further cycles of gemcitabine and nab paclitaxel.

6 weeks after you finish treatment you have a CT scan. This is so the doctors can see how well the treatment has worked. You might be able to have surgery to remove any cancer that is left if the cancer has shrunk a lot.

Quality of life

You fill in a questionnaire before you start treatment and at 5 other visits to the hospital. The questions ask about how you are feeling and any side effects you might have. This is a quality of life study.

Tissue samples

The team will ask for a piece of tissue (biopsy) form when you were first diagnosed.

They might also ask for a small piece of tissue if your cancer gets worse while having treatment. You don’t have to agree to have this sample taken if you don’t want to. You can still take part in the main trial.

The researchers use the tissue samples to find put more about pancreatic cancer and how to treat it.

Blood samples

You have a blood sample taken before you start nelfinavir to make sure you are fit enough to have it. And 2 after you finish treatment to see how well your body coped with the drug.

You might also have to have an extra blood test when the doctors are checking to see if you are able to join the trial. You will only have this if there are no recent blood test results available.

They will also ask for extra blood samples:

when you agree to take part in the trial

during treatment

after treatment has finished

if your caner gets worse

You don’t have to agree to have these blood tests if you don’t want to. You can still take part in the main trial.

Researchers will use these samples to find out more about pancreatic cancer and how to treat it.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include:

test to see how well your kidneys work, for example a 24 hour urine collection, if needed

You see the doctor regularly through treatment:

for blood tests

a physical examination

to see how you are

Once you have finished your treatment you see the doctors every 3 months for the first year. You have blood tests and a CT scan at these visits. After the first year your doctors will tell you how often they need to see you. They will also tell you what tests you need to have.

Side effects

The most common side effects of gemcitabine are:

a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

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